MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7210424
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during shoulder arthroscopy/anterior labrum repair, outside the patient, using accu-pass str shuttle 45 deg rght crve the handle could not be reloaded, the monofilament would stop progressing on the wheels.The procedure finished with a smith and nephew backup device.Surgical delay less than or equal to 30 minutes.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
D9: updated, device received.H3,h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A visual inspection revealed the device was returned without monofilaments and out of original packaging.The device shows no signs of stress or deformation.A functional evaluation revealed the wheels of the device functioned properly.Passage of monofilament could not be applied as not returned with device.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.No containment or corrective actions are recommended at this time.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11563591
• Report Number: 1219602-2021-00660
• Device Sequence Number: 4781801
• Product Code: LXH
• UDI-Device Identifier: 03596010534453
• UDI-Public: 03596010534453
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2023
• Device Model Number: 7210424
• Device Catalogue Number: 7210424
• Device Lot Number: 2061338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1